Cleared Traditional

K221728 - Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating (ACP) System, Reflex™ Hybrid ACP System, UniVise™ Spinous Process Fixation Plate

K221728 is an FDA 510(k) clearance for Aviator Anterior Cervical Plating (ACP)..., manufactured by Stryker Corporation. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K221728 · Stryker Corporation · Orthopedic device
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Optimized for regulatory review, auditing and printing
Oct 2022
Decision
127d
Days
Class 2
Risk

K221728 is an FDA 510(k) clearance for the Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran.... Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Stryker Corporation (Allendale, US). The FDA issued a Cleared decision on October 19, 2022 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Corporation devices

FDA 510(k) Submission Details - K221728

510(k) Number K221728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2022
Decision Date October 19, 2022
Days to Decision 127 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 122d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 583
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K221728.
CODA™ Anterior Cervical Plate System
K222493 · Pioneer Surgical Technology, Inc. · Nov 2022
Life Spine ALIF Buttress Plate System
K222628 · Life Spine, Inc. · Nov 2022
MONET Anterior Cervical Plate System
K220334 · Ctl Medical Corporation · Nov 2022
FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System
K222572 · Dio Medical Corporation · Oct 2022
CYGNUS™ MoRe Anterior Cervical Plate System
K220441 · MiRus, LLC · Sep 2022
VyPlate Anterior Cervical Plate System
K221572 · Vy Spine, LLC · Jul 2022